Each clinical trial is assigned a Trial Coordinator with experience in clinical research. The Trial Coordinator gains a thorough understanding of the client’s needs and requirements, whether it be for a domestic feasibility trial or a large, Phase IV international trial. This person assumes responsibility for all of the technical and administrative aspects of the study.
- Assist with the process of completing Clinical Trial Applications (CTAs) or Investigational New Drug (IND) applications
- Develop plans to manage regulatory requirements and regulations for importing and distribution
- Develop investigational product designs or formulations best suited tailored to the needs of clinical trials, as well as ensuring subject compliance
- Ensure the funding applications of trials are appropriately costed
- Source and procure commercial IMP, comparator products or other clinical trial materials
- Develop clinical trial documents or pharmacy manuals to ensure GCP compliance
- Develop GCP compliant laboratory manuals for central safety laboratory testing
- Source laboratory testing materials- vacutainers, cryovials etc and label appropriately
- Offer in house safety laboratory testing
- Develop or source out companion diagnostic testing
